(61 days)
PDO (Polydioxanone) Monofilament Synthetic Absorbable Sutures U.S.P. are indicated for use in general soft tissue approximation and/or ligation, including use in pediatric cardiovascular tissue where growth is expected to occur and ophthalmic surgery. PDO is not indicated for use in adult cardiovascular tissue, microsurgery and neural tissue. These sutures are useful where an absorbable suture with extended wound support (up to six weeks) is desirable.
The PDO (Polydioxanone) Monofilament Synthetic Absorbable Sutures, U.S.P. manufactured by ARC Medical and CP Medical are monofilament suture composed of a Poly(p-dioxanone) acid, un-dyed or dyed with D&C Violet No. 2.
The device is a PDO (Polydioxanone) Monofilament Synthetic Absorbable Suture. The study evaluated its equivalence to a predicate device and adherence to USP specifications.
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria (USP Specifications) | Reported Device Performance (ARC Medical PDO Suture) |
|---|---|
| Suture Diameter | Meets or exceeds USP specifications |
| Suture Length | Meets or exceeds USP specifications |
| Knot Pull Tensile Strength | Meets or exceeds USP specifications |
| Needle Attachment Strength | Meets or exceeds USP specifications |
| Absorption Rate | Meets or exceeds USP specifications |
| Equivalence to predicate device (CP Medical MONO-DOX) | Equivalent in terms of listed parameters |
2. Sample Size Used for the Test Set and Data Provenance:
The document does not specify the exact sample size used for the testing. It mentions "Testing of suture diameter, suture length, knot pull tensile strength, needle attachment strength and absorption rate." The provenance of the data is that it was generated by ARC Medical Supplies (Beijing) Co., Ltd. through their own testing. It does not mention if it was retrospective or prospective.
3. Number of Experts Used to Establish Ground Truth and Qualifications:
Not applicable. This study involves physical testing of a medical device against established standards (USP specifications) and comparison to a predicate device, not expert interpretation of diagnostic images or clinical scenarios.
4. Adjudication Method for the Test Set:
Not applicable. No expert adjudication method was described or needed for this type of device testing.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
Not applicable. This is not a diagnostic device or an AI-assisted device that would involve human readers.
6. Standalone (Algorithm Only Without Human-in-the Loop Performance) Study:
Not applicable. This is a physical medical device, not an algorithm or AI system. The tests performed are standalone device performance tests.
7. Type of Ground Truth Used:
The ground truth used for this study consisted of:
- USP (United States Pharmacopeia) XXIII specifications: These are established, legally recognized standards for medical devices like sutures, defining acceptable ranges for properties such as diameter, length, strength, and absorption.
- Predicate device characteristics: The characteristics of the MONO-DOX synthetic absorbable polydioxanone surgical sutures manufactured by CP Medical were used as a comparative ground truth to demonstrate equivalence.
8. Sample Size for the Training Set:
Not applicable. This is a physical medical device, not an AI or machine learning model that requires a training set.
9. How the Ground Truth for the Training Set Was Established:
Not applicable as there is no training set for this type of device.
§ 878.4840 Absorbable polydioxanone surgical suture.
(a)
Identification. An absorbable polydioxanone surgical suture is an absorbable, flexible, sterile, monofilament thread prepared from polyester polymer poly (p-dioxanone) and is intended for use in soft tissue approximation, including pediatric cardiovascular tissue where growth is expected to occur, and ophthalmic surgery. It may be coated or uncoated, undyed or dyed, and with or without a standard needle attached.(b)
Classification. Class II (special controls). The special control for the device is FDA's “Class II Special Controls Guidance Document: Surgical Sutures; Guidance for Industry and FDA.” See § 878.1(e) for the availability of this guidance document.